Medical device companies provide assemblies and kits containing medical implements such as needles, syringes, sutures, wire guides, introducer sheath assemblies, and the like to clinicians to be used for particular medical procedures. Commonly, at least some of the medical implements are obtained from external suppliers, which are then combined with the others to form the assemblies and the kits prepared for an end user typically for an intended medical procedure. All of the implements regardless of their source are sterilized, for example by an ethylene oxide (ETO) process, during the assembling process and/or during prior to use by the end user.
Each medical implement is placed either in a single sealed pouch that is combined with other single sealed pouches within a larger sealed outer pouch, or directly within an outer tray with a sealed lid. However, for low volume packaging, outer tray packaging can be relatively expensive per unit cost. Because of the high relative costs, outer pouch sealing can become more commercially viable option.
For outer pouch packages, the assembler typically seals each medical implement within its own single pouch, and then seals a specific combination of medical implements within the outer pouch. To seal within a single pouch, an assembler will insert each medical implement within an individual pouch in a first step. The individual pouches, which are typically purchased from a supplier, are shaped and sized to receive the medical implement therein. The individual pouches are pre-sealed from the supplier along three sides and have an opening at a fourth side to receive the medical implement. After insertion of the medical implement, a seal is formed along the fourth side of each individual pouch by an assembler in a second step. The first and second steps of the assembling process require additional time and labor during the assembling process, and thus results in additional manufacturing costs per assembly or kit.
To seal the single sealed pouches within a larger outer pouch, an assembler will insert all of the individually sealed pouches within a larger outer barrier pouch in a third step. The outer barrier pouch, which is typically purchased from a supplier, has a single compartment that is sized to contain all of the individually sealed pouches which contain the medical implements. The outer barrier pouch is pre-sealed from the supplier along three sides and have an opening at a fourth side to receive all of the individually sealed pouches. A seal is then formed along the fourth side of the outer barrier pouch by an assembler in a fourth step.
To access the medical implements contained within the assembly or kit prior to a medical procedure, the end user would first have to open the outer pouch. The end user would then have to open each of the individual pouches that contain the medical implements. Consequently, each individual pouch is a single use item and discarded as waste. Hence, what is needed is an assembly or a kit for containing medical implements that can be packaged less expensively than the prior art. In particular, multiple medical implements can be assembled within the assembly or the kit in fewer process steps and/or with less material so that the assembly or the kit is environmentally friendly and results in reduced environmental wastes and costs of recycling for end users.